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A First in Human Trial Evaluating THB335 in Healthy Participants

NCT06425861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-19

No results posted yet for this study

Summary

This study is a double blind, randomized, placebo-controlled, Phase 1 study in three parts: single ascending doses and food effect (Part 1), multiple ascending doses (Part 2) and Relative Bioavailability of Two Formulations (Part 3).

Conditions

  • Healthy

Interventions

DRUG

THB335 single dose

Single dose as oral capsule

DRUG

Single dose placebo

Single dose as oral capsule

DRUG

THB335 fasted/fed

Single dose fasted and fed as oral capsule

DRUG

Placebo fasted/fed

Single dose fasted and fed as oral capsule

DRUG

THB335 multiple dose

Multiple ascending doses oral capsule

DRUG

Multiple dose placebo

Multiple doses oral capsule

Sponsors & Collaborators

  • Third Harmonic Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · QPS Holdings LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2024-12-18
Completion
2024-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425861 on ClinicalTrials.gov